Clearance Summary
UltraSight Guidance received FDA 510(k) clearance under submission number K251416, sponsored by Ultrasight , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2025-12-17.
- Submission: K251416
- Applicant / Sponsor: Ultrasight , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2100
- Decision date: 2025-12-17
Classification & Regulation
This clearance is catalogued under FDA product code QJU and 21 CFR 892.2100, within the Radiology review panel as a Class II device.